Effects of Seven Day Prucalopride Administration in Healthy Volunteers

University of Oxford

Status

Completed

Conditions

Antidepressive Agents

Mental Disorders

Molecular Mechanisms of Pharmacological Action

Cognition

Depression

Mood Disorders

Depressive Disorder

Treatments

Other: Placebo

Drug: Prucalopride

Study type

Interventional

Funder types

Other

Identifiers

NCT03572790

Pruc_7d

Details and patient eligibility

About

This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive seven days administration of either prucalopride (1mg daily) or placebo. All participants will come for a Screening visit, Research Visit One (including an MRI scan) and Research Visit Two (including measures of emotional processing and non-emotional cognition). The primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. A secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. Finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.

Enrollment

50 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant is willing and able to give informed consent for participation in the study
Male or female
Aged 18-40 years
Sufficiently fluent English to understand and complete the task
Right handed
Body Mass Index in the range of 18-30
Not currently taking any medications (except the contraceptive pill)

Exclusion criteria

Not fluent in English
Any past or current Axis 1 DSM-V psychiatric disorder
Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
Current usage of any medication that will influence the MRI scan
Current or past history of drug or alcohol dependency
Currently pregnant or breastfeeding
Study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week)
Not right handed
Body Mass Index outside the range of 18-30
History of cardiac, thyroid, or liver problems
An autoimmune disorder
Current, or a history of, gastro-intestinal disorder or irritable bowel syndrome
Epilepsy
Known lactate deficiency or any other problem absorbing lactose, galactose, or glucose
Participation in a study which uses the same computer tasks as those used in the present study
Participation in a study that involves the use of a medication within the last three months
Smoker > 5 cigarettes per day
Typically drinks > 6 caffeinated drinks per day
Any contraindication to MRI scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)